A phase IV, interventional, non-blinded, randomized, controlled, multicenter study of posaconazole prophylaxis for the prevention of influenza-associated aspergillosis (IAA) in critically ill patients
- Conditions
- Influenza-associated aspergillosisAspergillus infection on top of influenza1002146010017528
- Registration Number
- NL-OMON46362
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
1. Written informed consent must be obtained from the patient or his/her legal representative prior to any study procedures;
2. Adult patient (>= 18 years);
3. PCR-confirmed influenza in nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) fluid within 7 days prior to ICU admission or within 48 hours after ICU admission. If PCR is not available, a positive result of a rapid test is required (a negative rapid test does not imply absence of influenza and thus requires confirmation by means of PCR);
4. Influenza symptoms present for no more than 10 days prior to ICU admission;
5. Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with a respiratory rate >= 25/min. and a PaO2/FiO2 ratio <= 300 with or without (bilateral) infiltrates on radiographic chest studies
1. Pregnant women (based on a positive serum sample);
2. Expected survival on ICU admission <= 48 hours;
3. Patients being transferred from another hospital ward or another hospital who already have mycological evidence of invasive aspergillosis (based on sputum, BA or BAL fluid culture; BAL fluid or serum galactomannan);
4. Patients with known intolerance of or hypersensitivity to posaconazole;
5. Patients actively treated with antifungal agents active against Aspergillus species;
6. Patients actively treated with rifampicin or rifabutin
7. Patients with a QTc interval >= 500 milliseconds on electrocardiography (ECG);
8. Patients with liver cirrhosis (Child-Pugh classification C);
9. Participation in another investigational clinical trial;
10. Any disorder which, in the investigator's opinion, might jeopardize subject's safety or compliance with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in IAA incidence at ICU discharge between the intervention and<br /><br>control group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Time to IAA diagnosis<br /><br>- Length of ICU stay<br /><br>- Length of hospital stay<br /><br>- Overall mortality<br /><br>- 30-day mortality<br /><br>- 90-day mortality<br /><br>- Presence of markers of MAS in blood<br /><br>- Cytokine production by peripheral blood mononuclear cells (Nijmegen site only)<br /><br>- Reactive oxygen species (ROS) production by peripheral blood<br /><br>polymorphonuclear cells/neutrophils (Nijmegen site only)<br /><br>- Frequencies in single nucleotide polymorphisms/mutations in relevant genes<br /><br>(Nijmegen site only)</p><br>